The drug regulatory authorities in the Netherlands have approved Schering AG's new oral contraceptive Yasminelle. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European wide marketing approval.
Yasminelle contains 20 micrograms ethinyl estradiol and three milligrams drospirenone in a 21-day active pill intake regimen. Yasminelle is similar to Schering's oral contraceptive Yasmin but offers a lower estrogen dose with the unique progestin, drospirenone.
"Yasminelle adds to our rich product portfolio that has helped us become the global leader in contraception. Yasminelle will build upon the success of Yasmin, which is the number one oral contraceptive worldwide. We plan to soon offer European women this new low-dose oral contraceptive with the well known pharmacodynamic profile of drospirenone," said Philip Smits, Head of Gynaecology & Andrology at Schering AG. "We are well on track with developing the Yasmin family. In addition, we are currently awaiting US approval for YAZ, a drospirenone-containing oral contraceptive with a new 24-day active pill regimen," he said.